Tablet identification using near-infrared spectroscopy (NIRS) for pharmaceutical quality control

Journal of Pharmaceutical and Biomedical Analysis

Volumn 48, Issue 1, 2008, Pages 62-69

  Alvarenga, L ^a   Ferreira, D ^a   Altekruse, D ^b   Menezes, J C ^a   Lochmann, D ^b  

^a INSTITUTO SUPERIOR TÉCNICO   (Portugal)

^b Merck Serono GmbH   (Germany)

Author keywords

API; ICH Q2; ICH Q6; NIRS; Quality control; Tablet identification

Indexed keywords

THIAMAZOLE;

ARTICLE; DRUG DETERMINATION; DRUG IDENTIFICATION; DRUG QUALITY; NEAR INFRARED SPECTROSCOPY; PRIORITY JOURNAL; QUALITY CONTROL; TABLET; VALIDATION STUDY;

CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; GUIDELINES AS TOPIC; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; SPECTROSCOPY, NEAR-INFRARED; TABLETS, ENTERIC-COATED; TECHNOLOGY, PHARMACEUTICAL;

EID: 49749152439     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.05.007     Document Type: Article

References (30)

1. Reich G. Adv. Drug Deliv. Rev. 57 (2005) 1109-1143
2. Roggo Y., Jent N., Edmond A., Chalus P., and Ulmschneider M. Eur. J. Pharm. Biopharm. 61 (2005) 100-110
3. Gupta A., Peck G.E., Miller R.W., and Morris K.R. J. Pharm. Sci. 94 (2005) 1589-1597
4. Stordrange L., Libnau F.O., Malthe-Sørenssen D., and Kvalheim O.M. J. Chem. 16 (2002) 529-541
5. Blanco M., and Alcala M. J. Pharm. Sci. 27 (2006) 280-286
6. Blanco M., and Romero M.A. Analyst. 126 (2001) 2212-2217
7. Candolfi A., De Maesschalck R., Massart D.L., Hailey P.A., and Harrington A.C.E. J. Pharm. Biomed. Anal. 19 (1999) 923-935
8. Vredenbregt M.J., Caspers P.W.J., Hoogerbrugge R., and Barends D.M. Eur. J. Pharm. Biopharm. 56 (2003) 489-499
9. Aldridge P.K., Mushinsky R.F., Andino M.M., and Evans C.L. Appl. Spectrosc. 48 (1994) 1272-1276
10. Blanco M., Eustaquio A., González J.M., and Serrano D. J. Pharm. Biomed. Anal. 22 (2000) 139-148
11. Dempster M.A., Jones J.A., Last I.R., MacDonald B.F., and Prebble K.A. J. Pharm. Biomed. Anal. 11 (1993) 1087-1092
12. Herkert T., Prinz H., and Kovar K.-A. Eur. J. Pharm. Biopharm. 51 (2001) 9-16
13. Krämer K., and Ebel S. Anal. Chim. Acta 420 (2000) 155-161
14. Blanco M., Coello J., Eustaquio A., Iturriaga H., and Maspoch S. J. Pharm. Sci. 88 (1999) 551-556
15. de Maesschalck R., and van den Kerkhof T. J. Pharm. Biomed. Anal. 37 (2005) 109-114
16. Van den Kerkhof T., Maesschalck R., Vanhoutte K., and Coene M.C. J. Pharm. Biomed. Anal. 42 (2006) 517-522
17. Skibsted E., Westerhuis J., Smilde A., and Witte D. J. Pharm. Biomed. Anal. 43 (2007) 1297-1305
18. The European Agency for the Evaluation of Medicinal Products, EMEA, CPMP/QWP/3309/01, London, 2003.
19. International Conference on Harmonisation (ICH) of Technical Requirement for Registration of Pharmaceuticals for Human Use, Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, Q6A, ICH, 1999.
20. International Conference on Harmonisation (ICH) of Technical Requirement for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology, Q2, ICH, 2005.
21. Gottfries J., Depui H., Fransson M., Jongenelen M., Langkilde F.W., and Witte D.T. J. Pharm. Biomed. Anal. 14 (1996) 1495-1503
22. Thosar S.S., Forbess R.A., Ebube N.K., Chen Y., Rubinovitz R.L., Kemper M.S., Reier G.E., Wheatley T.A., and Shukla A.J. Pharm. Dev. Technol. 6 (2001) 19-29
23. Broad N., Graham P., Hailey P., Hardy A., Holland S., Hughes S., Lee D., Prebble K., Salton N., and Warren P. In: Chalmers J.M., and Griffiths P.R. (Eds). Handbook of Vibrational Spectroscopy (2002), John Wiley & Sons Ltd., Chichester
24. Kirsch J.D., and Drennen J.K. J. Pharm. Biomed. Anal. 19 (1999) 351-362
25. Ressler N., Ziauddin C., Vygantas W., Janzen K., and Karachorlu. Appl. Spectrosc. 30 (1976) 295-302
26. Bokobza L. In: Siesler H.W., Ozaki Y., Kawata S., and Heise H.M. (Eds). Near-Infrared Spectroscopy - Principles, Instruments, Applications (2002), Wiley-VCH Verlag GmbH, Weinheim 11-42
27. Heise H.M., and Winzen R. In: Siesler H.V., Ozaki Y., Kawata S., and Heise H.M. (Eds). Near Infrared Spectroscopy: Principles, Instruments, Applications (2002), Wiley-VCH Verlag GmbH, Weinheim 125-162
28. Næs T., Isaksson T., Fearn T., and Davies T. A User-Friendly Guide to Multivariate Calibration and Classification (2002), NIR Publications, Chichester
29. Bruker Optik GmbH, Spektroscopic Software OPUS Version 5.5 Manual, 2004.
30. Borer M.W., Zhou X., Hays D.M., Hofer J.D., and White K.C. J. Pharm. Biomed. Anal. 17 (1998) 641-650